[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1878 Thiamine mononitrate.
(a) Thiamine mononitrate
(C12H17N5O4S, CAS Reg. No.
532-43-4) is the mononitrate salt of thiamine. It occurs as white
crystals or a white crystalline powder and is prepared from thiamine
hydrochloride by dissolving the hydrochloride salt in alkaline solution
followed by precipitation of the nitrate half-salt with a stoichiometric
amount of nitric acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 325, which is incorporated by reference. Copies
are available from the National Academy Press,
2101 Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Thiamine mononitrate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[48 FR 55124, Dec. 9, 1983]
Additives that reference this regulation: